Friday, January 27, 2012

“In any discussion involving science or medicine, citing Whale.to as a credible source loses the argument immediately, and gets you laughed out of the room.”

Anyone who has ever dealt with Lowell Hubbs (or any vaccine conspiracy theorist for that matter) knows they can't resist the temptation to link to whale.to as if it is a reputable source of scientific information. I equate this to someone who would cite the website The Onion as a legitimate source of news... which sadly has actually happened.

Have I also mentioned the most offensive information is their belief that the Holocaust never happened? Yes... these are the people that Lowell Hubbs and his fellow antivaxers actually treat as trusted sources. Amazing... yet disgusting.

“If you have to insist that you've won an internet argument, you've probably lost badly.”

So why do I mention Danth's Law you ask? Well... it seems rather fitting considering the following quotes were recently submitted from Lowell Hubbs:

"YOU LOSE......AGAIN!!!!!!!!!!!!!!"

"Like I said, you lose every time"

"Like I said you are a loser and you always will be a loser in these matters."

"That makes YOU a loser, quite clearly."

"You are a very sick and in denial loser Costner, and you always were."

"THAT makes YOU a complete loser the likes of that has rarely been seen before, if ever."

"You lose, alias no identity Costner, again and again and again!"

"You lose, again. Any honest person can see that."

Methinks thou dost protest too much indeed. Aside from the fact he doesn't appear to have any originality in his words and he is a bit of a broken record, the saddest part is that Hubbs submitted the bulk of these all within a few days of one another. Apparently he believes if he tells himself something long enough he might actually start to believe it.

Hey... at least someone is convinced.

Mind you none of this has anything to do with the effectiveness of vaccines, but it does show you the sad and pathetic tactics a vaccine conspiracy theorist will go to in order to feel as if they are actually "winning" an argument. I've witnessed these same tactics from countless antivaxers on numerous website and forums, and it seems the most common character trait all of these people share is their inability to be intellectually honest coupled with a severe misunderstanding of what debate actually is.

Whether it be an inherent reliance upon logical fallacies, a blatant disregard for what is considered fact vs. opinion, a desire to exclude accepted science when it differs from their viewpoints, or a habit of actually rewriting history to suit their own wishes, these antivaxers rarely are able to engage in a civil scientific discussion based upon facts. It just doesn't seem to happen, and logic must be tossed aside like last year's phone book if you wish to entertain the idea of a discussion with one of these people.

Perhaps it doesn't really matter. Antivaxers will always be convinced they are right and everyone else is wrong. They will likely continue to ignore science and they will continue to move the goal posts time and time again. One day they will tell you the MMR vaccine causes autism, but when that theory is proven incorrect they will claim thimerosal causes autism. When thimerosal is removed they will claim the aluminum causes autism, when it is show to not be the case they will claim it is some other ingredient.

When they can't nail down a specific ingredient they will move on to the more generic reference of toxins. When you ask them to specific a particular component they are forced to backtrack and claim it is the number of vaccines. When you point out that autism rates don't fluctuate between those children who are up to date on all the recommended vaccines versus those who are only partially vaccinated they claim it is a combination of any and all vaccines.

When you cite information showing once selection bias is removed, there is no compelling evidence to suggest unvaccinated populations are diagnosed with autism at a lower rate they claim we need more studies and larger studies and more specific studies... all the while continuing to parrot the same tired arguments that vaccines cause autism or some other random neurological disorder even though they have zero scientific evidence to support their views.

This is why the scientific community won't waste time "debating" vaccine conspiracy theorists, because the truth is you cannot debate someone who refuses to abide by the laws of common sense. If someone refuses to accept fact as fact, and refuses to acknowledge accepted science then there is no valid reason to engage them in a civilized debate, because the debate would like be neither civilized nor a debate.

The reality is that entertaining a vaccine conspiracy theorist via an honest debate is a futile effort, because vaccine conspiracy theorists attempt to argue based upon misbelief and misunderstanding. They enter a discussion with firm beliefs that they will admit cannot be swayed by any amount of scientific evidence, and when backed into a corner and pressed with information, they simply change their position and attempt to switch the subject. If all else fails, they simply state there is some conspiracy at play which explains why they cannot support their opinions with facts or science.

We've seen this many times with Mr. Hubbs. He jumps from conspiracy to conspiracy with no connection between them, and when asked direct questions his only response seems to be a generic statement that there is "to [sic] much to lose" along with five, 10, or 20 unrelated urls to various conspiracy websites. As such, it seems the one thing Hubbs seems to be actually good at is declaring himself to be the "winner" in any debate he attempts to enter, even though (as is the case with most of his beliefs) he seems to be the only one that holds that particular viewpoint.

The bottom line is, if someone is convinced the sky is red... you will never convince them that it is blue. In the case of a vaccine conspiracy theorist they would likely try to redefine the term "red" rather than admit they might have been wrong, and this is why so the antivaxer community will most likely never be taken seriously.

Tuesday, January 24, 2012

Based upon my previous blog post about Dr. Stanislaw Burzynski, Lowell Hubbs thought it was his duty to ensure the Burzynski Clinic knew about it. Thus, like the good little CAM foot soldier that he is, he took it upon himself to send an email to Burzynski (and sent me a copy just for kicks). It reads as follows:

Subject: Information on a blog trashing and slandering Burzynski Clinic, as Quackery.

This blog is as well [sic] has been an ongoing and endless and slanderous personal attack on me. Quack of the Day: Dr. Stanislaw Burzynski http://lowellhubbs.blogspot.com/2012/01/quack-of-day-dr-stanislaw-burzynski.html This is my counter blog: […] I have followed Dr Burzynski’s work for quite some time, and I am obviously a strong supporter of his work and treatment, in the ways that I can. This blog I above referenced to [sic] has a clear pattern of slandering and bashed [sic] any alternative information and/or truth promoting doctor on the planet. This is my site: Dr. Burzynski […]

Obviously I removed the references to Mr. Hubbs own blogs/websites because I'm not about to steer traffic his direction and I have an unwritten rule about only linking to scientifically credible websites (with exceptions given for comedic and shock value). However the remainder of the email is posted as written... broken English and all (the URL referenced in Mr. Hubbs' email has since changed so it no longer functions).

Let me translate Mr. Hubbs' comment into what it really means. Basically it says “Oh this big mean person is picking on me and I don’t like it, so I’m going to tell the Burzynski Clinic about it in the hopes that if I massage their ego enough and tell them how great they are, they will think I’m special and go after him to shut down his blog once and for all”.

Mr. Hubbs also decided to add to his email when he forwarded a copy of it to me - that text is as follows:

"And as far as your again twisted and slanderous claims as to how Burzynski handed the blogging and other unwarranted attacks on his practice; when you actually read what is there, it is not even close to what you claim it is at all. He handled those situations professionally and in the legal manner they should be. If informing a person to cease and desist their slanderous behavior in print, is classified as threat in your mind, so be it. Wow." ~Lowell Hubbs

Sadly for Mr. Hubbs, his childish antics won’t work.

First of all Mr. Hubbs doesn't appear to understand the difference between slander and libel (even though it has been explained to him numerous times), and since this blog is in written form what he is really looking for is the term libel. Since Hubbs can’t seem to distinguish between the two, perhaps it would be best if he would consider using the more generic term of defamation.

Either way, my statements about Burzynski are far from libelous. First of all I doubt anything on this blog is honestly defamatory to Burzynski’s reputation since his reputation has already taken a significant hit, and either way the truth can't be defamatory. When I refer to the facts about his legal troubles, the facts that his associates have went after random bloggers, or the facts about how he has been working with antineoplastons for more than 30 years and yet he has been unable to publish any reputable peer-reviewed studies validating their usage… those are not libelous statements as they are true.

I am also not incorrect that Burzynski has been performing never-ending clinical studies or how he has yet to perform any phase III randomized, controlled trials of antineoplastons as a treatment for cancer. These are not opinions – these are facts. So what exactly does Hubbs consider to be defamatory in nature when I’m either stating facts, or I’m stating an opinion? Have I stated anything I don’t believe to be true? No. Have I presented information as fact with reckless disregard on whether the information is true or not? Clearly not as I have even sourced the majority of my statements.

If Hubbs is going to toss out the claim of slander (libel), he might want to take a few minutes out of his hectic day to educate himself. I would suggest he start with Underwager v Salter 22 F.3d 730 and New York Times Co. v. Sullivan 376 U.S. 254. What he would find is in order to claim defamation, the public figure (in this case Burzynski) would need to prove actual malice (aka "ill will"). This means they would need to prove that I did not believe the statements I wrote (which is impossible since I believe them), or they would need to prove that I published these statements without any concern whether they were true or not (I care, which is why I didn't even bother to mention numerous accusations about Burzynski that I was unable to verify or that I felt did not have sufficient supporting evidence to ensure they were factual).

I don't wish to get into a conversation about US tort law, but the bottom line is Hubbs has no idea what he is talking about, and I'm quite certain that Burzynski's PR team is well aware of US law surrounding libel which is why Burzynski staffers chased after bloggers in the UK rather than the US. However, even that wasn’t sufficient and you will note out of the individuals whom I listed in the original blog as having been chased after by Burzynski’s staff they all still have their blogs up and running.

Hubbs seems to think Burzynski's team handled those situations professionally when in fact they ended up sending out an apology for Mr. Stephens’ behavior and they were backpedaling faster than watching the Tour de France in reverse. They even ended their relationship with Stephens (according to their own press release) and they apologized for the incidents.

Apparently Hubbs didn’t bother to actually read all of the emails sent from Mr. Stephens to Rhys Morgan where Mr. Stephens actually threatened to contact Mr. Morgan’s school and where he even went so far as to send him a Google satellite image of his house in some type of veiled threat. Hubbs obviously also appears to have overlooked the other few dozen emails Mr. Stephens sent on behalf of Burzynski, or even the responses left by Mr. Stephens (aka "MAS") over at Yahoo Answers where he attempted to post personal information about people he disagreed with, where he made veiled threats against others, and where he even stooped to calling people "ugly" and "senile". Mind you his tactics didn't work and his responses were incredibly childish, but it just goes to show how low these people will stoop in order to silence their critics.

Thus if Hubbs honestly believes threatening 17-year olds via email equates to acting “professionally”, or chasing people around on Yahoo Answers is appropriate, then so be it. Apparently we will have to agree to disagree on that one, however I find it incredibly telling that Burzynski had to issue an apology for the very actions Hubbs claims were professional.

Perhaps it would be best if Hubbs took the time to actually read the material I cite before commenting. This just doesn’t seem to be working out for him, but then again... nothing ever does. So what was the response to Hubbs' email to the Burzynski Clinic? Read on:

Good evening, Thank you for your e-mail. We did see the “Quack of the Day” blog. It’s sad and unfortunate that some individuals can be so cruel, evil, and closed minded in their behavior even with the facts clearly in front of them. We will focus on doing what is right and that is treating our patients and giving them the attention they need. Thank you again for your support.

I find it interesting that the Burzynski Clinic seems to have already reviewed my blog even before Hubbs had sent them a message, which must mean I'm doing something right to get noticed. Well OK they probably just have a Google Alert set up for key search terms like "Burzynski" and "Quack"... but it makes me feel special either way.

I also find the humor in how they describe my blog as "cruel" and "evil" yet they are unable to cite any specific statements which are untrue. Newflash for Azad... the truth can sometimes be cruel, but you have your employer to blame for that.

Either way you can see they really don't seem to care about my blog, just as they likely don't care about the few dozen other blogs that have been written about Burzynski. Perhaps that lack of concern stems from the fact that they know the content of these blogs is actually true. Or perhaps the lack of concern is because they know the more they try to silence their critics, the more critics will appear (a variation of the Streisand effect). Although either of these reasons could be legitimate, I'm guessing it likely has to do with them not wanting to focus upon random bloggers while they are preparing for Dr. Burzynski's appearance in front of the Texas Medical Board, which is scheduled for April of this year.

Needless to say, I fully expect to be writing more about Dr. Burzynski in the future - especially after a decision has been rendered after the April hearing. Until then, Mr. Hubbs will need to continue to proclaim how Burzynski is the brave maverick doctor who is worthy of respect and who should never be challenged.

Friday, January 20, 2012

Lowell Hubbs doesn't believe that the polio vaccine was the reason that the US no longer has to fear polio, and he has even gone so far as to blame sugar for the polio epidemic. I've discussed this idiocy in the past (the comments are often the best part), but for whatever reason Hubbs is still convinced that polio vaccines are worthless.

For this reason, I thought he might enjoy a recent article which explains how India is very, very close to finally wiping out polio... all due to a vaccine.

Wednesday, January 18, 2012

Cancer. Just the word itself causes people to gasp as they wonder if it will impact them or their loved ones. If you ask a typical person about their families, chances are they have lost at least one person close to them from cancer, or they may have fought cancer themselves. In fact, it is estimated that over 40% of the public will be diagnosed with cancer at some point during their lifetimes, so there is good reason to be concerned.

Cancer can impact everyone. It impacts both men and women, both young and old, and members of all races. In some cases, if detected early, cancer can be treated and the cancer can be considered to be in remission. In other cases, a late cancer diagnosis which has metastasized to numerous parts of the body can essentially be a death sentence. Although treatments have improved and death rates have fallen, there is still no known cure.
Because of this, it is not uncommon for people to fear cancer. It is not uncommon for cancer patients to try every possible treatment known to man even if some of those treatments are experimental or unproven. It is also not uncommon for medical conspiracy theorists to proclaim some random doctor or self-proclaimed cancer expert has a miracle cure that can treat cancer patients or that this miracle cure is being suppressed by "Big Pharma", the FDA, AMA, CDC, WHO, or some other random government agency.

This is where Dr. Stanislaw Burzynski comes into play. Burzynski has positioned himself as a victim. He claims he can treat and in many cases even suggests he can cure cancer, but because his treatments would negatively impact the pharmaceutical companies or mainstream cancer treatment centers (and thus suggesting it would harm their bottom-line), he is being unfairly targeted and muzzled from speaking the "truth" about cancer.

Thus, Burzynski has decided the best way to get his message out to the masses is to star in a movie about himself to share his story, and of course like all the other alternative medicine mockumentaries prior, the movie serves no legitimate scientific benefit and is heavily biased. Of course the glaring lack of peer-reviewed science or supporting evidence is irrelevant to a medical conspiracy theorist, and as such the alternative medical proponents such as Lowell Hubbs have latched on to this little film as evidence of some massive conspiracy. They will even go so far as to cite it as a legitimate source of data, and they will refer to the film as if it was a true unbiased and scientifically supported documentary.

It really shouldn't surprise anyone that Mr. Hubbs would be a fan of Burzynski, because Mr. Hubbs is a fan of pretty much anyone who labels themselves as a practitioner of alternative medical therapies, or anyone who has ever positioned themselves as the antithesis to mainstream modern medicine. Thus, true to form, Mr. Hubbs has inundated my inbox with comment after comment bragging about Burzynski and his miracle cancer cures.

Burzynski himself isn't exactly new to the cancer scene, and he has been involved in his research for around 35 years. Burzynski focuses upon what he calls "antineoplaston therapy" and he offers his treatments at his clinic located in Houston, Texas. Initially, Burzynski was extracting these antineoplastons from urine he collected from the restrooms in public parks (which is why Mr. Hubbs has stated in the past that a doctor was able to cure cancer by extracting a substance from urine), but later Burzynski synthesized the antineoplastons in a lab as it was obviously much easier, and much less expensive.

It should be noted that antineoplaston therapy has never been approved by the FDA, and Burzynski has published no peer-reviewed science in support of his treatments. Burzynski has been approved to perform FDA testing on his treatments, yet to date, no phase III randomized, controlled trials of antineoplastons as a treatment for cancer have been conducted. Ever. Read that again - in the 35 years that Burzynski has been performing clinical trials on antineoplastons, no phase III randomized, controlled trials of antineoplastons as a treatment for cancer have been conducted. This means that Burzynski has never performed a study to compare his antineoplaston therapy against more conventional therapies, and it doesn't appear he has any immediate plans to do so.

Burzynski has actually performed some clinical trials, namely phase I and phase II trials, yet the results of those trials remain unpublished. Out of 61 clinical trials listed under Burzynski's name, 50 of them are in an unknown status, seven have been withdrawn, two were terminated, one is not yet recruiting, and in one single case, Burzynski has actually finished his phase II clinical trial. So out of a total of 61 trials reported in the past 35 years only one has been finished, yet where is the peer-reviewed science showing the magical results? The reality is, 60 of the 61 trials listed are phase II clinical trials, and the only phase III trial listed is the one that states it is not yet recruiting. The information was submitted in December 2010 with a start date listed as December 2011 and a completion date of December 2015, yet there haven't been any updates and it appears it still pending as "not yet open for participant recruitment".

Based upon this information, we only have one single study to focus upon, and that was the phase II trial that dealt with how well antineoplaston therapy works in treating patients with progressive or recurrent stage IV melanoma. The trial was started in 1996 and shows as completed in 2005, so what is the explanation on why the results haven't been published?

If the results don't prove that antineoplaston therapy is effective, then why is he continuing to promote it? If the results do suggest that antineoplaston therapy is effective in treating cancer, why hasn't the data been published for all to see? What purpose does it serve to suppress data if he has faith in the outcome of his clinical trial? The fact is antineoplaston therapy is still considered experimental, so why is Burzynski promoting it as a legitimate treatment even before publishing results of his own studies?

As you can see there are a lot of questions, but Burzynski doesn't appear to be offering many answers. It seems that although he can't legally treat patients with antineoplaston therapy, he can enroll them into one of his many clinical trials, so this little loophole has allowed Burzynski to operate his clinic for 35 years even though he has never published any results from those trials in any reputable peer-reviewed journals. One might assume that such a "visionary" would want to share his treatments and clinical results with the world in order to have an honest impact upon the future of cancer treatments... but alas that doesn't appear to be the case with Burzynski.

Of course Burzynski is no stranger to controversy or the courtroom either. He has been involved in various court cases since at least 1983, ranging from violations of the Food, Drug, and Cosmetic Act to fraud to... well more fraud. It seems most recently, Burzynski has found himself being investigated once again by the Texas Medical Board, although that case is currently pending and a hearing is scheduled for April 2012.

I'm sure there are others, but perhaps if Burzynski would spend as much time focused upon producing scientific data as a result of his neverending clinical trials rather than chasing after random bloggers who happen to think he is a fraud or a quack, he might actually get somewhere. Then again, it is safe to say if the results of his ongoing trials were actually impressive, we would have read about them decades ago.

It would seem when you really examine the data, Burzynski simply doesn't have the science or research to support his viewpoints, and I find it disturbing that he promotes the myth that he can so easily cure cancer without any scientific basis to make such a claim. He gives cancer victims and family members false hope, and he hasn't shown his treatments are effective at anything other than shrinking the size of a person's bank account.

I of course could go into much more detail about Burzynski, his impressive claims, his lack of scientific data, and his little movie, but why repeat what has already been done?

All of this aside, claims that a miracle cure exists for cancer won't even hold up against common sense. Cancer is not just one lone medical condition that responds to a one-size-catch-all treatment. Cancer encompasses many different forms of the disease which all present themselves differently and which respond to treatments differently. To suggest there is any one treatment that can so easily cure so many various forms of cancer immediately raises suspicion.

If such a cure was readily available, and if such a cure actually worked the medical insurance industry would be spending tens of millions of dollars to ensure the studies were fully funded and that the treatment was in widespread use. Conventional cancer treatments can run into the hundreds of thousands of dollars or even more, yet Burzynski's antineoplastons can be synthesized and are available from medical suppliers for as little as 80 cents per dose. Doesn't that seem like something the insurance industry could get behind in order to drastically slash their costs and improve their profits?

Either way, we find ourselves in familiar territory here because once again we are being told the only reason these miracle cures aren't in widespread use is because there is some conspiracy at work. Burzynski staff members, medical conspiracy theorists, alternative medical gurus, and "Internet researchers" are quick to list any number of excuses on why Burzynski's hypothesis have yet to be published or why there is no peer-reviewed science supporting his claims, but at the end of the day that is just what they are... excuses.

The reality is antineoplastons have been studied elsewhere outside of Burzynski's clinic, and yet there have been no indications that they work as well as Burzynski has claimed. Japanese scientists at the Kurume University School of Medicine have studied antineoplastons as have researchers from Mansoura University in Mansoura, Egypt. Their results generally reflect a lack of activity, however that isn't to say there isn't any benefit to them at all or that continued research is worthless, but the current reality is they are not a miracle cure as we have been led to believe.

If antineoplastons are really as effective as Burzynski claims, or if they are a viable cancer treatment, then by all means Burzynski has the option... or rather the duty, to publish his findings for all to see. I think we all know why that hasn't happened - and it has more to do with keeping the steady flow of scared, ignorant patients coming through the doors year after year than it does from his research somehow being suppressed or manipulated.

Meanwhile people continue to die from cancer each and every day while proponents of complimentary and alternative medicine (CAM) attempt to convince us that cancer can be cured via unproven treatments and snakeoil.

Some people have no shame... and unfortunately in this case that lack of shame leads to false hope, increased suffering, and unnecessary expense.

Friday, January 13, 2012

If you spend any time researching vaccines and autism and the amount of research devoted to these two areas, you will soon discover that many antivaxers (including our very own Lowell Hubbs) claim the only reason there have not been any large scale medical studies comparing vaccinated populations and unvaccinated populations (aka "vax vs. unvax") is because the government is afraid of what the study might show. Other conspiracy theories include accusations that "big pharma" wouldn't allow such a study, or that these studies have been performed but the results are so damning that they have never been released to the public.

As is so often the case, asking for evidence of these claims is a futile effort. Conspiracy theories don't come with supporting evidence and instead we are just supposed to trust that antivaxers are telling the truth even if they can't prove it. Apparently when it comes matters of science, facts don't matter and it is simply a matter of trust. Makes sense right?

Of course trying to explain to a conspiracy theorist that you cannot prove a negative is a gigantic waste of time. Trust me... I've tried. Many, many, many times. I have repeatedly made the point that if someone believes there is a link between vaccines and autism it is their duty to prove it, but that line of reasoning doesn't sit well with those making the point because they don't want to be bothered to actually perform the research. They are more than happy to make unsubstantiated claims, but when asked to provide the evidence the only response comes in the form of an excuse or yet another conspiracy theory on why they can not or will not bother to produce evidence to support their beliefs.

If we ignore the fact that the antivaxer community is unwilling to support their views with evidence, we are left with their all-too-common fallback plan where they claim it is up to the government (or some other group) to prove autism doesn't cause autism, which as you can tell leads is right back to the issue with proving a negative. This type of circular logic and the pattern of "evade, excuse, deny, project" is witnessed time and time again, because the typical antivaxer realizes he or she can't argue their point based upon facts or science, so they must instead try to talk around the issue and resort to pointing the finger elsewhere whether that be the government, pharmaceutical companies, university researchers, or wherever else the dart happens to land on that given day.

The reality is, there are many reasons why such large scale "vax vs. unvax" studies haven't been performed. One primary reason includes the necessary sample size required to get a definitive answer. Aside from the logistical nightmare of trying to convince the parents of unvaccinated children to allow scientists and doctors to monitor and test them, and aside from the ethical implications of essentially endorsing that a group of children remain unvaccinated, the core of the problem rests is the number of children required for such a study to be performed.

Another problem is even if you did "prove a negative" and prove there is no such link between vaccines and autism, how could you convince the antivaxers that this is the case? We already have seen numerous studies on various vaccines and on specific vaccine components such as thimerosal which have been unable to show any link between vaccines and autism yet even the growing pile of evidence is not enough to convince many antivaxers, so why would a large scale study comparing vaccinated children against unvaccinated children be any different?

I came across a very well written post recently that discussed these issues and more, and it is a post worth reading. Using basic math coupled with an understanding of how studies are performed, the author (who is a parent of an autistic child) outlines how it would be nearly impossible to perform such a study unless you were able to include practically every single unvaccinated child in the entire nation. Even then there is doubt the results would be acceptable to the antivaccination crowd... and if they refused to acknowledge what the data shows - what is the benefit of such a study?

The author also brings up another very valid point about scientific funding. He goes into more detail, but it boils down to the fact that every dollar spent researching fairy tales to appease the minds of conspiracy theorists is one less dollar that could be used to research legitimate treatments or conditions. That is typically a trade-off that ethical scientists and researchers are unwilling to gamble with considering there are lives at stake.

For anyone with a sincere interest in the idea of a "vax vs. unvax" study, this is definitely worth a look:

Update July 2013: Unfortunately the Photon In The Darkness site is no longer available, and therefore I'm going to post the entire article here for reference. I was able to find this via the Internet Archive Wayback Machine but in the off chance it disappears I want to ensure it is available for future readers since it was a very well written and popular piece:

Once again, there is a hue and cry to “do a study” about vaccines and autism, this time pushed forward by commentors on David Gorski’s recent post on the “Science-Based Medicine” ‘blog. Whenever I hear people who have never tried to do any study - let alone a study of human children - say “We need to do a study!”, I can’t help thinking of Mickey Rooney and Judy Garland and their “Let’s put on a show!” musical films - ergo the title of this article.

As I expected, the commentors put forth many of the same arguments that haven’t worked before but this time they are doing their math, something I appreciate. So, in appreciation, I have prepared the following:

The Reason:

The interest in “doing a study” seems to stem from the idea that the only way to find if vaccines are connected with autism is to study unvaccinated children and compare their autism prevalence with vaccinated children. This is nottrue and is - in fact - not even the most effective way to study the postulated connection, as I will show later.

Much of the blame for this wrong-headed fixation on “Just study the unvaccinated!” can be laid at the feet of Dan Olmsted, who claimed that the Amish don’t vaccinate and don’t have autism. Both claims - it turns out - are untrue. The Amish do vaccinate and they do have autism. Apparently, Mr. Olmsted didn’t look in the right places for his information about the Amish. And if you don’t look, you never find.

The same argument - if you don’t look, you don’t find - has been used to argue for studying the “connection” between autism and vaccines. However, researchers have looked. They looked at thimerosal and autism - and found no correlation. They looked at the MMR vaccine and autism - and failed to find a correlation. Now, with their backs against the wall, the vaccines-cause-autism believers have shifted from distinct vaccines or vaccine components to vague “toxins” or the even more vague “too many, too soon”.

Despite an absolute lack of data supporting either claim (’toxins” or “too many, too soon”), the proponents have argued that “we need to do a study” of vaccines and autism. “We” (i.e. the taxpayers) may indeed end up “putting on a study” in response to the political pressure these groups may bring to bear. I have no illusions that any research will ever be able to convince these people that they are wrong. After all, they haven’t been swayed by any research done so far.

However, since we’re all going to end up paying for this study, we should ask that it be done in the most effective way possible, rather than simply following the uninformed dictates of the vaccines-cause-autism believers.

The Amish:

Let me dispose of one line of “reasoning” that often comes up when these “Let’s put on a study” promoters gather. It is often suggested that we “take advantage” of existing groups of people who do not vaccinate their children. Mr. Olmsted proposed the Amish, although it later turned out that the Amish do vaccinate their children, although not at the level seen in the population at large. Another proposed study group was a health care group in Chicago that practiced non-vaccination and also - we are told - had a low to zero autism rate.

The problem with selecting “special” populations to study is that they are not comparable to the general public. The Amish - probably the most dramatic example - have a much higher prevalence of several genetic disorders as a result of generations of inbreeding. They are not comparable to the US population for this reason and any results obtained from studying them would be irrelevant. I suspect the main reason for wanting to study the Amish was that Mr. Olmsted “found” that they don’t have any autism - which was, as I’ve said above, also incorrect.

Even if we were to study a group like that in Chicago, the question would arise, “What other differences (besides vaccination) are there?” Do they only eat organic foods? What else might account for any differences between them and the general population. And if no difference in autism prevalence were discovered, would that be enough to satisfy the folks crying to “put on a study” or would they simply shift their sights to another group?

No, the only way to correctly do a study of vaccines and autism is to compare children who are matched for age, sex, geographic location, rural/urban/suburban setting, socio-economic group and race. That way, theonly differences (we hope) would be vaccination status and autism prevalence.

The Numbers:

If we’re to do a study (as opposed to “putting on” a study), we need to have an idea of the numbers of subjects we’ll need to test in order to come up with a statistically meaningful result.In 2004, Smith et al published “Children who have received no vaccines: Who are they and where do they live?”. This was an extensive study of vaccination practices in the US, carried out from 1995 to 2001 on over 23,000 children selected at random to be representative of the larger population. Their results were interesting and bear directly on the desire to “put on a study” looking at the connection (or lack thereof) between vaccines and autism.What they found was that 62.8% of their study population was “fully vaccinated” (i.e. had received all the vaccines on the then-current vaccination schedule - 15 total in 2001). An additional 36.9% were “undervaccinated” - although 58.5% of them (20.4% of the total sample) were missing only one vaccine. Only 0.3% of the sample - 111 children ages 19 - 35 months over five years - had not received any vaccination.

I’d like to emphasize a point. The Smith et al study only looked at children 19 - 35 months of age, which is wellbefore school age, at which time undoubtedly a few more tenths of a percent of the unvaccinated were whittled away. However, this age includes the ages where children have been reported to have “regressed into autism” following vaccines.

So, any study of unvaccinated vs vaccinated children has to deal with the fact that the “pool” of unvaccinated children is about 0.3% (or less) of the total population. Even if we could extend the Smith et al findings to the entire 0 - 17 year age range (”children”, by most definitions), this works out to only about 223,000 completely unvaccinated children. Given that at least some of the children who were unvaccinated before 35 months will have gotten at least one vaccination by their teen years, this number is sure to be much smaller.

For the purposes of this demonstration, let’s limit the study group to younger children, both to eliminate the uncertainty about the number of unvaccinated children and to keep the diagnostic criteria somewhat comparable. After all, the criteria used to diagnose the 17 year-old autistic children were very different from those used today.How about we settle on the 3 - 6 year age range? This puts them past the scheduled time for the majority of childhood vaccinations and yet cuts off before the “school vaccination mandate” years. According to the US census bureau, this age group (as of August 2008) contains 16,550,753 children. Of that number 49,652 (or less) might be completely unvaccinated (and over ten million “completely vaccinated”).

What sort of sample numbers do we need to “prove” the vaccine-austism question? Well, let’s make a few assumptions. The first assumption is that we will want to have a sample size large enough to be sure that we have less than a 5% chance of mistakenly saying there is a correlation if there isn’t (alpha error) - and we’ll want a less than 5% chance of saying there isn’t a correlation if there is one (beta error) in order to satisfy those who want to “put on a study” (normally, we’d accept a 20 - 50% chance of mistakenly saying that there is not a difference when there is one).

Secondly, we’ll have to stipulate what sort of difference we expect to find between the two groups. If the “fully vaccinated” group had 50% more autism than the “unvaccinated” group, would that be enough of a reason to change vaccination policies? Would a 10% difference be enough? More to the point, how small a difference will be small enough for the vaccine-cause-autism proponents to say “I was wrong, vaccines don’t cause autism.”?That last point may be the one that actually torpedoes the study. Because if there is no number small enough to convince those who want the study that they are wrong, most of the reason for doing the study vanishes.

Let’s say - for the sake of argument - that we decide that a 10% difference in autism prevalence is enough to convince the skeptics that vaccines might cause autism and that a less than 10% difference will convince the believers that vaccines don’t cause autism. [I know, the latter assumption is pure fantasy.]

Well, plugging those numbers in - along with the current 1 in 150 autism prevalence - we find that we need over 360,000 children in each group to detect a 10% difference (you can try it yourself here). Unfortunately, that is more than the total number of unvaccinated children in the US, so that’s not going to happen.

What can we get with our “sample” of 49,652 unvaccinated children? If we manage to include each and every unvaccinated child in the US in the study, we could detect a 26% or more difference in autism prevalence.

Of course, it’s not even remotely practical to expect to get 100% of the unvaccinated children in the country into a study. How about a more practical number - say, 10% of them? That would allow us to detect a 70% or greater difference - about a three-fold difference in autism prevalence between the fully vaccinated and unvaccinated groups.

Now, if a difference of this magnitude or greater were found, that would pretty effectively silence those who say that the data haven’t shown a connection between vaccines and autism. I would certainly change my opinion (from “not shown” to “strong indication”).

But what if the results go the other way? What if the results are “negative”, meaning that the difference is less than 70%? Would that be enough to get the vaccines-cause-autism crowd to stop protesting and stop sending death threats? I doubt it.

Of course, there are those who believe that the results will be unambiguously in favor of their belief that vaccines-cause-autism. They want the study to go forward because they are confident that they will be vindicated. They are also the people who will rant about “bias”, “flaws” and “corruption” if the data don’t go “their way”.Another other thing to consider is that a study with almost ten thousand children enrolled would be exorbitantly expensive, especially as they would all have to be tested carefully for autism. Even using a very conservative figure of $150 for an evaluation, that’s over $1.5 million just for the autism testing.

Don’t forget that research money, time and facilities are not infinite. Resources spent chasing the vaccines-cause-autism “connection” will have to come from other research areas, and the most fair way to do that would be to take them from other autism research. Thus, much time and money is spent to accomplish little…or nothing.

And is it likely that you could get the parents of 10% of the unvaccinated children in the country to enroll them in a study? Given that many of these children are unvaccinated because their parents harbor deep suspcions about doctors and “the government”, it seems unlikely.

Finally, let’s “run the numbers” on a more practical study - one where we are able to enroll 500 unvaccinated children and 5000 fully vaccinated controls matched for age, sex, socioeconomic group, geographic location, urban vs rural vs suburban setting and race.

This study - which would still be very difficult and expensive to do - would only be able to detect a more than 15-fold difference in autism prevalence between the two groups. It could detect as little as a 7-fold difference, but only if we were willing to accept a beta error (chance of erroneously saying there is no difference when there is a difference) of over 50%.

I doubt this would “satisfy” the vaccines-cause-autism believers if the results were negative.

So, before someone tells me - again - how easy it would be to study autism in unvaccinated children, first go out and try to find a few thousand completely unvaccinated children and then tell me how easy it is.

Ethical Considerations:

Another suggestion made was to have a study where children are placed into “no vaccination” and “vaccination” groups. This, of course, would be rejected out of hand by any Institutional Review Board because the risks of notvaccinating are well known and quite serious. On the other hand, the connection between vaccines and autism is tenuous at best. It would be unethical to expose adults to a known serious risk in order to test a weakly-supported (again, at best!) possible risk. In children, it would be unthinkable.Another “modest proposal” was to vaccinate one group per the suggested schedule and vaccinate another group with four times the amount of vaccine. Well, at least this commentor understands the concept of “dose-response”. If - as some people argue - the current amount of vaccine is causing some amount of autism, then it would be reasonable to expect that more vaccine would lead to more autism.

Of course, the idea of doing something with the intent of causing harm to children is unlikely to pass the ethical hurdles of a real IRB. However, even if the hypothesis is incorrect - even if the researchers argue that harm isextremely unlikely, they would still be exposing children to four times the dose used during the safety trials of the vaccines, which would constitute an unreasonable risk, especially to test a hypothesis that is already weak.Additionally, if the results are “negative”, the vaccines-cause-autism proponents could (and would) argue that their hypothesis is correct but that the threshold for causing autism is lower than the “standard” vaccine regimen (you know, the “too many, too soon” argument). Thus, the argument for doing the study (absent the obvious ethical considerations) has largely disappeared.

An Alternative:

Part of the difficulty in doing a study of unvaccinated children is tracking them down. There is no national or even statewide database that can “spit out” the names of unvaccinated children; you’d have to track them down one by one, a process that can take years to complete, given the numbers needed.Additionally, the proposed study design wastes the effort used to collect the subjects based on a single variable - vaccination.A much better study design would be to look at two age, sex, etc. matched sets of autistic and non-autistic children. Autistic children are more “visible” in the medical and educational systems than unvaccinated children (who are often “under the radar”). It would be easier (although not easy) to recruit autistic children and non-autistic control subjects than it would be to track down thousands of unvaccinated children.

Another advantage is that the researchers could collect data on a wide variety of exposures, genetic issues and other variables that could later be “mined” to find other promising avenues of research. This in contrast to the “single issue” study looking at unvaccinated children, which can only compare issues related to vaccination.

Even with those advantages, the study will be “swimming upstream” a bit.A study of autistic children in the 3 - 6 year age range would need over 683,000 children in each group to detect a 10% difference in vaccination level. It would need nearly 22,000 in each group to detect a 50% difference. With a predicted number of 110,000 autistic children in that age range, that is a sizeable fraction of all autistic children.

A more manageable study - one with 10,000 children in each arm (which is still a HUGE study!) - would only be able to tell the difference between the national average of 0.3% unvaccinated in the non-autistic group and 0.1% unvaccinated in the autistic group (at the specified levels of confidence). If the difference is smaller than that, the results would be considered negative (i.e. that there is no effect of vaccination). For reference, a study with 1,000 children in each arm would show statistical significance (at our specified level of confidence) only when the autistic group was below 0.01% unvaccinated or above 1.7% unvaccinated.

Of course, we wouldn’t have to just look at unvaccinated vs fully vaccinated with this study, which is a large part of its superiority. We could look at a dose response of vaccination - to see if it really is “too many” - as well as the age at youngest vaccination - to see if it really is “too soon”. In fact, a few studies have already looked at those issues and found that there is no difference between the autistic and non-autistic groups. I suspect this is the reason the folks pushing to “put on a study” want to look at vaccinated vs unvaccinated - they hope that the numbers will be different (or, at least, not as definitive) the other way round.

Conclusions:

The current push to “put on a study” comparing the autism prevalence in vaccinated and unvaccinated children is likely to come to political fruition long before it generates any real scientific interest. Anyone who has actually done a human study will recognize that the proposed study format - find a bunch of unvaccinated kids and compare their autism prevalence to the general population - has serious problems.

If our political leaders eventually find it expedient to “put on a study” in a vain attempt to quiet the protests of the vaccines-cause-autism fringe, then we need to be prepared to insist that it be a proper study, not a rigged “study” pre-ordained to find the “correct” results.

Thursday, January 5, 2012

I recently read an article and an associated report that I found very interesting. One of the rather shocking statistics from the report is that from 1990 through 2008, death rates from cancer fell almost 23 percent for men and around 15 percent for women. It is estimated this has resulted in over one million lives saved.

The senior author of the report is Dr. Ahmedin Jemal who is vice president for surveillance research at the American Cancer Society (ACS). Dr. Jemal stated these reductions "largely reflect improvements in prevention, early detection and treatment."

Although the actual incidence rate for cancer has changed very little, it seems modern medicine is making great advances in treatment which is allowing cancer patients to live longer lives. I won't go so far as to say anyone with cancer is ever fully "cured" although we do know cancer can go into remission for years, decades, or perhaps a lifetime.

The interesting thing is that although the death rates for cancer continue to drop, we continue to see alternative medicine proponents such as Mr. Hubbs claim the exact opposite. They seem to think modern medicine is part of the problem rather than the solution, and they tend to believe there are unknown doctors and experts out there who can fully cure cancer with up to a 100% success rate.

Granted people can claim whatever they wish, but the real science proves that modern medicine is getting better at treating cancer, better at diagnosing cancer, and better at prolonging lives - while the conspiracy theorists and snakeoil salesman are never able to support their claims with any peer-reviewed science to independent validations.

So whether it be claims about baking soda curing cancer, or extracting substances from urine, or some miracle, super-secret biomedical treatment, they all talk a big talk, but they never produce any evidence to support they are honestly able to cure (or even treat) cancer like they claim. Aside from other alternative medicine proponents echoing the same lines to one another and repeating the same cliches time and time again, we never seem to see any legitimate data to support their claims... even after years of being promised a report is "just around the corner" or that a study will be published "soon".

In the end, it is statistics like those within this report that show us that real doctors, hospitals, and researchers are making a difference each and every day - and they are on the right path.

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